Senior Clinical Study Lead — Rare Hematology/Immunology

Regeneron Pharmaceuticals, Inc.; New Jersey; Hybrid; USD 151.000 - 246.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Scientist to lead design, execution, and interpretation of clinical studies within a cross-functional matrix.

This role supports rare hematologic conditions and/or immunologic diseases and collaborates with Medical Directors to advance programs. You will ensure compliance with FDA, EMEA, ICH, and GCP standards, author key documents, mentor junior staff, and contribute to safety data reviews across the trial lifecycle.

Qualifikationen

• 8+ years of pharmaceutical clinical drug development experience.
• Experience in rare hematologic conditions and/or immunologic diseases.
• Knowledge of GCP, clinical study design, and clinical research methodology.

Aufgaben

• Lead clinical study design, execution, and data interpretation across a full development program.
• Collaborate with Medical Directors and cross-functional teams to shape study strategy.
• Author and review protocols, amendments, and clinical study reports.
• Ensure FDA/EMEA/ICH/GCP compliance across study activities.
• Mentor junior team members within Clinical Sciences.

Kenntnisse

GCP knowledge

Study design

Cross-functional collaboration

Data interpretation

Mentoring

Ausbildung

Bachelor's degree

Advanced degree

Jobbeschreibung

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Scientist to lead design, execution, and interpretation of clinical studies within a cross-functional matrix.

This role supports rare hematologic conditions and/or immunologic diseases and collaborates with Medical Directors to advance programs. You will ensure compliance with FDA, EMEA, ICH, and GCP standards, author key documents, mentor junior staff, and contribute to safety data reviews across the trial lifecycle.